Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders (RESPYR-SBA)
9 de junio de 2026 actualizado por: Respyr
Early Identification of Metabolic Function Derangements Such as Diabetes, Liver, Renal Issues by Respyr Smart Breath Analyzer and Its Validation as a Screening Tool Among Diseased and Healthy Controls
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
The study will be conducted with healthy participants and participants with known cases of diabetes, kidney related issues, liver related issues, and lung related issues as confirmed by pathology reports.
In phase 1, 500 apparently healthy individuals with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test will be recruited.
In phase 2, 500 patients of type 2 diabetes, liver function, renal function, and lung function derangements each diagnosed by 10% increment above normal values will be enrolled.
In phase 3, validation of the breath analyzer as a screening tool for early identification of type 2 diabetes, liver, renal, lung and other metabolic function derangements will be done by randomly assigning healthy and diseased participants for exhaled breath sample analysis.
The study is based on the principle of exhaled breath analysis where parts per million and parts per billion level of volatile organic compounds and gases in human breath will be measured.
AI based algorithms will be generated to effectively screen unhealthy biomarker levels, enabling timely preventive action.
Descripción general del estudio
Estado
Terminado
Descripción detallada
The smart breath analyzer, Respyr is an IoT and deep-tech enabled portable device developed by Humors Tech Pvt Ltd, Bangalore, India. The device measures volatile organic compounds (VOCs) and gases at parts-per-million and parts-per-billion levels in exhaled breath using AI and ML-based algorithms to identify metabolic derangements non-invasively.
Registration Details:
The study is registered with CTRI (CTRI/2022/09/045983) and ethics approval has been obtained from the Institutional Ethics Committee of JSS Medical College, Mysore (Ref: JSSMC/IEC/260822/07/CT Final Approval/2022-23, dated 19.12.2022). Protocol number: HTB-PROTOCOL-01, Version 1, dated 07 March 2022.
Testing Procedure:
Participants will provide an exhaled breath sample under fasting conditions, or with a minimum gap of 1 hour after consuming water and 3-4 hours after consuming food. The breath analyzer readings will be compared against standard laboratory diagnostic values including FBS/RBS, RFT, LFT, spirometry, and lipid profile, all tested within 15 days of participation.
Regulatory Compliance:
The study follows ICH-GCP guidelines, CDSCO-DCGI and New Drugs and Clinical Trial Rules 2019, and ICMR Ethical Guidelines for Biomedical Research on Human Participants.
Tipo de estudio
De observación
Inscripción (Actual)
3000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Karnataka
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Mysore, Karnataka, India, 570015
- Dept. of Community Medicine, JSS Medical College
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Healthy volunteers and patients with confirmed metabolic disorders including type 2 diabetes, liver disease, kidney disease, and lung disease recruited from JSS Hospital and Medical College, Mysore, India.
Descripción
Inclusion Criteria:
- Participant must either be a completely healthy individual as confirmed by blood examination, or a known case of diabetes, kidney disease, liver disease, and lung disease with relevant diagnostic reports tested within 15 days of participation
- All genders and ethnicities
- Age 18 to 75 years
- Participant who has given informed consent
- Participant must be fully vaccinated for COVID-19
- Participant must use the smart breath analyzer at fasting condition; if not fasting, minimum gap of 1 hour after water and 3-4 hours after food
Exclusion Criteria:
- Individual less than 18 or above 75 years of age
- Pregnant and lactating females
- Known case of ongoing illness such as Cancer, AIDS, COVID-19, Cough, Fever, TB, Chickenpox, Influenza, Mumps, or Tonsillitis
- Individual who has not given informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Healthy Volunteers
Apparently healthy individuals aged 18-75 years with normal levels of fasting and postprandial blood sugar, renal function test, liver function test, and lung function test, as confirmed by blood examination conducted within 15 days of participation.
Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.
|
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Patients with Metabolic Disorders
Patients aged 18-75 years with confirmed diagnosis of one or more metabolic disorders including type 2 diabetes (confirmed by FBS/RBS), kidney disease (confirmed by RFT), liver disease (confirmed by LFT), and lung disease (confirmed by spirometry), with relevant diagnostic reports tested within 15 days of participation.
Participants will undergo exhaled breath analysis using the Respyr smart breath analyzer device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Validation of Smart Breath Analyzer for Screening of Metabolic Disorders
Periodo de tiempo: Baseline
|
Development and validation of an IoT and deep-tech enabled smart breath analyzer for accurate and early screening of metabolic derangements including diabetes, kidney disease, liver disease, lung disease, AI and ML-based algorithms will be generated to provide an affordable, non-invasive screening option enabling timely preventive healthcare action
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Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Triglycerides
Periodo de tiempo: baseline
|
Measured in mg/dl.
Normal range: <150 mg/dl.
Compared with smart breath analyzer readings.
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baseline
|
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HDL
Periodo de tiempo: baseline
|
Measured in mg/dl.
Normal range: 40-60 mg/dl.
Compared with smart breath analyzer readings.
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baseline
|
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VLDL
Periodo de tiempo: Baseline
|
Measured in mg/dl.
Normal range: 2-30 mg/dl.
Compared with smart breath analyzer readings.
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Baseline
|
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LDL
Periodo de tiempo: Baseline
|
Measured in mg/dl.
Normal range: 100-129 mg/dl.
Compared with smart breath analyzer readings.
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Baseline
|
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Cholesterol/ HDL Ratio
Periodo de tiempo: Baseline
|
Ratio with no unit.
Normal range: <4.5.
Compared with smart breath analyzer readings.
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Baseline
|
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LDL/HDL Ratio
Periodo de tiempo: Baseline
|
Ratio with no unit.
Normal range: <3.
Compared with smart breath analyzer readings.
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Baseline
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Serum Protein Level (Total Protein, Albumin, Globulin) assessed by Liver Function Test (LFT)
Periodo de tiempo: Baseline
|
Measured in g/dl.
Normal ranges: Total Protein 6.4-8.3 g/dl, Albumin 3.4-4.8
g/dl, Globulin 2-3.5 g/dl.
Compared with smart breath analyzer readings.
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Baseline
|
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Serum Creatinine Level assessed by Renal Function Test (RFT)
Periodo de tiempo: Baseline
|
Measured in mg/dl.
Normal range: 0.7-1.3
mg/dl.
Compared with smart breath analyzer readings.
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Baseline
|
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Fasting Blood Glucose Level assessed by Fasting Blood Sugar Test (FBS)
Periodo de tiempo: Baseline
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Measured in mg/dl.
Normal range: 75-110 mg/dl.
Compared with smart breath analyzer readings.
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Baseline
|
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HBA1C (4.0-5.6)
Periodo de tiempo: Baseline
|
HbA1c Level assessed by Glycated Hemoglobin Test
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Baseline
|
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Post Prandial (<140)
Periodo de tiempo: Baseline
|
Postprandial Blood Glucose Level assessed by Post Prandial Blood Sugar Test (PPBS)
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Baseline
|
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Total/Direct/Indirect Bilirubin
Periodo de tiempo: Baseline
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Serum Bilirubin Level (Total, Direct, Indirect) assessed by Liver Function Test (LFT)
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Baseline
|
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SGOT/AST (<37 U/L)
Periodo de tiempo: Baseline
|
SGOT/AST Level assessed by Liver Function Test (LFT
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Baseline
|
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ALP (30-90 U/L)
Periodo de tiempo: Baseline
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Alkaline Phosphatase (ALP) Level assessed by Liver Function Test (LFT)
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Baseline
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Total Protein, Albumin, Globulin, A/G ratio
Periodo de tiempo: Baseline
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Serum Protein Level (Total Protein, Albumin, Globulin, A/G Ratio) assessed by Liver Function Test (LFT)
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Baseline
|
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Serum urea (13-43 mg/dl)
Periodo de tiempo: Baseline
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Serum Urea Level assessed by Renal Function Test (RFT)
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Baseline
|
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Uric acid (3.5-7.2 mg/dl)
Periodo de tiempo: Baseline
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Serum Uric Acid Level assessed by Renal Function Test (RFT)
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Baseline
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Calcium, Phosphorus
Periodo de tiempo: Baseline
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Serum Calcium and Phosphorus Level assessed by Renal Function Test (RFT)
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Baseline
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Sodium, Potassium, Chloride
Periodo de tiempo: Baseline
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Serum Electrolytes (Sodium, Potassium, Chloride) assessed by Renal Function Test (RFT)
|
Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nayanabai Shabadi, M.D, JSS Medical College, Mysore
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de octubre de 2022
Finalización primaria (Actual)
3 de octubre de 2023
Finalización del estudio (Actual)
5 de octubre de 2023
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del sistema endocrino
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Enfermedades pulmonares
- Diabetes Mellitus, Tipo 2
- Enfermedades del HIGADO
- Enfermedades Renales
- Enfermedades metabólicas
Otros números de identificación del estudio
- HUMORS-CTRI-2022-045983
- CTRI/2022/09/045983 (Identificador de registro: Clinical Trials Registry India)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data contains proprietary device output from a commercially sensitive medical technology.
Data sharing is restricted due to intellectual property considerations and patient confidentiality
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .